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Intramuscular Aripiprazole Provides Rapid and Long-lasting Treatment for Agitated Psychotic Patients: Presented at APA

By Bruce Sylvester

NEW YORK, NY -- May 6, 2004 -- Aripiprazole 10 mg intramuscular (IM) reduces acute agitation in patients with psychosis rapidly and without excessive sedation or pain at the injection site, researchers reported here May 5^th at the American Psychiatric Association Annual Meeting.

"The most important finding of this study is that in patients with schizophrenia and schizoaffective disorder who were involved in a 24-hour double blind placebo-controlled trial, 10 mg of intramuscular aripiprazole emerged as a rapidly effective and very well tolerated treatment for agitation," said David Daniel, MD, lead researcher and Clinical Director, Bioniche Development, Mclean, Virginia. "The effect was apparent at 30 minutes and it was sustained for 2 hours."

In the multicenter, 24-hour, double-blind, placebo-controlled study, the investigators enrolled 357 patients who presented with acute agitation and randomized them to placebo or aripiprazole IM 1 mg, 5 mg, 10 mg, or 15 mg, or haloperidol IM 7.5 mg.

The key outcome measure was Positive and Negative Syndrome Scale (PANSS)-Excited Components (PEC), which the researchers evaluated every 15 minutes during the first 2 hours of treatment.

The investigators reported that aripiprazole 10 mg IM achieved rapid reduction of PEC versus placebo (at 30 min: -3.2 vs. -1.76, P =.051; 45 min: -4.39 vs. -2.22, P <.05; 60 min: -5.48 vs. -2.41, P <.05) and that treatment efficacy was maintained for the entire 24-hours of the study.

Haloperidol showed significant improvement versus placebo at 105 minutes, Dr. Daniel said. Also, aripiprazole IM achieved significant improvement in agitation without excessive sedation, as measured by the Agitation-Calmness Evaluation Scale.

Aripiprazole IM was associated with pain at the injection site in 1.8% of subjects. Two patients withdrew from the trial due to adverse events.

"The finding that intramuscular aripiprazole is a well-tolerated treatment for agitation associated with schizophrenia and schizophrenia-like illness is an exciting milestone for severely ill schizophrenic patients, families and those who treat these patients," Dr. Daniel said. "To have an intramuscular formulation of an atypical antipsychotic such as aripiprazole means that, from the very start, patients can be seamlessly treated with the same medicine in different formulations, a medication that has unprecedented tolerability."

"It is important to note that intramuscular aripiprazole is in the development stage, that the presented [data] at this meeting are extremely exciting, positive and encouraging," Dr. Daniel added. "We will await further replication in subsequent studies."

Oral aripiprazole is marketed in the U.S. as Abilify. The study was supported by Bristol-Myers Squibb and Otsuka Pharmaceutical Co., Ltd.


[Presentation title: "Intramuscular aripiprazole in acutely agitated psychotic patients." Abstract # NR612]

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